Tag medicalmalpractice

All adverse outcomes cannot be prevented; however, defensibility is strengthened when care rendered is consistent with standards of care.

In this blog I’ll provide a brief overview of Hypoxic Ischemic Encephalopathy (HIE) neonatal brain injury.  I will review the definition, the incidence (U.S. and worldwide), associated complications, possible causes, and recommended treatment.  I will also share possible defenses to consider when developing a HIE neonatal brain injury case. 

What Is It? HIE neonatal brain injury is injury to the brain as a result of hypoxia.  Hypoxia is a deficiency of well oxygenated tissue.  This can result from a combination of insufficient blood flow and/or decreased oxygen levels. 

How Common Is HIE? HIE is the leading cause of brain injury in the perinatal period.

• Occurs in 1 to 8 of every 1,000 live births in the United States
• HIE causes 30% of cerebral palsy cases in the United States
• HIE causes 23% of neonatal deaths world-wide. The fifth leading cause of deaths worldwide in children under 5 years of age (World Health Organization, 2020).

Complications of HIE (including, but not limited to…): cerebral palsy, epilepsy, mental retardation, visual impairment, hearing impairment, learning disabilities, cardiac arrest, death.

Causes (including, but not limited to…) of HIE neonatal brain Injury: (literature suggests 70-80% of HIE neonatal brain injury cases are not preventable)

1. Antepartum and Intrapartum Events – placental abruption, umbilical cord prolapse, uterine rupture, acute blood loss (maternal hemorrhage), infection
2. Maternal Underlying Risk Factors – hypotension, hypertension, placental vasculopathies, insulin dependent diabetes
3. Neonatal Risk Factors – congenital heart disease, pulmonary disease, severe apnea, patent ductus arteriosus, hypoglycemia, hyperglycemia, meconium aspiration syndrome, infection

Treatment:  Therapeutic hypothermia, or induced cooling, has been shown to reduce death and disability in many HIE cases.  Reduction in the core body temperature reduces the brain temperature resulting in neuroprotection.  Therapeutic hypothermia is the standard of care for infants who are diagnosed with moderate to severe HIE following birth (no later than 6 hours of life) and who meet specific criteria per standard of care adopted by organizational policy, procedure, and order set. 

*Sarnat Staging System is the standard of care to grade severity of HIE

Cooling can be done on the whole body, or through a cooling cap placed on the head.  The infant may need other medical interventions to support their organs or to treat seizures.

Infants who experience HIE may require early intervention therapy services after discharge.  These include services from a neurodevelopmental pediatrician, physical therapist, occupational therapist, speech therapist, feeding and swallowing therapist, and/or a pediatric neurodevelopmental ophthalmologist.

Possible Plaintiff Allegations for HIE Neonatal Brain Injury:

Failure to transfer mother to tertiary care center (higher level of care)

Failure to or delay in transferring infant to Level III NICU for hypothermia therapy

Failure to attend or delay in arrival of a NICU team to a high-risk delivery

Failure of medical staff to recognize and treat neonatal seizures

Failure of Midwife to have appropriate resuscitative equipment and personnel for home delivery

Failure to follow hypothermia treatment protocol

Possible Defenses for HIE Neonatal Brain Injury:

The infant did not meet criteria for hypothermia protocol

The manifestations of the brain injury were metabolic or genetic in nature and not a result of HIE

The infant was not stable for transport to a higher level of care

The mother was non-compliant with regimen for high-risk pregnancy conditions

The mother had no prenatal care

Synthesis of Data and Case Development:  Knowing which relevant maternal and infant medical records to request and what questions to ask are essential.  Having an awareness of standard physician orders, and standing nursing orders will support the development of a case.  A strong understanding of the electronic medical record and documentation requirements, as well as standard laboratory and diagnostics ordered will support case development. 

Below are some clinical areas of focus for case development:

• pathophysiology of fetal monitoring and fetal strip interpretation: identification of fetal hypoxia
• acid-base balance: identification of fetal and/or neonatal metabolic acidosis
• newborn Apgar scoring: identification of the presence of birth asphyxia
• gestational age assessment: evaluation of the appropriateness of implementing hypothermia treatment
• staging and classification criteria for HIE: identification of the level of neurological compromise, identification of eligibility criteria of newborn for hypothermia treatment
• hypothermia treatment: identification of treatment as the standard of care, criteria for treatment, treatment modalities, procedure, staff competencies and continuing education

Perinatal Safety and Professional Liability: All adverse outcomes cannot be prevented; however, defensibility is strengthened when care is consistent with relevant, current evidence-based practice recommendations and standards of care. 

P.S. Comment and Share: What were your successes and challenges working through a HIE birth injury case?

References:

Douglas-Escobar & Weiss. (2015). Hypoxic-Ischemic Encephalopathy: A review for the clinician. JAMA pediatrics. 169(4):397–403. doi:10.1001/jamapediatrics.2014.3269 

Simpson K.R., & Creehan P.A. (2020). AWHONN’s Perinatal Nursing. 5^th edition. Lippincott Williams & Wilkins

World Health Organization. (2020). Newborns: improving survival and wellbeing. https://www.who.int/news-room/fact-sheets/detail/newborns-reducing-mortality

World Health Organization. (2022). The top 10 causes of death. https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death

Facts found within the electronic medical record (EMR) and electronic health record (EHR), or missing from either source, can strengthen or weaken a medicolegal case.  Having an understanding of the EMR and EHR is crucial to the discovery process.   In this blog, I’ll be addressing the differences between the EMR and EHR.  I will also share EMR and EHR elements to consider for discovery. 

Differences Between the EMR and EHR: The EMR is an electronic record of health-related information on an individual that can be gathered, stored, managed, and consulted by authorized clinicians and staff within one healthcare organization.  The EHR is also an electronic record of health-related information on an individual, however, it must conform to nationally recognized interoperability standards.  The EHR can be created, managed, and consulted by authorized clinicians and staff across more than one healthcare organization (McBride et al., 2019).

Discovery: Discovery involves procedures for obtaining information (admissible to trial) from other parties, and witnesses prior to trial. 

Objective: The purpose of discovery is to get the facts, narrow down the issues of the case, identify the strengths and weaknesses of the case, plan a trial strategy, or negotiate a settlement. 

Having someone knowledgeable about the EMR and EHR systems on the legal team proves to be a valuable approach to success.  The reason for this is that there are many elements of the EMR and EHR to consider in the process of discovery. McBride et al., (2019) references that there are unintended consequences of missing the patients story secondary to “data noise.” These unintended consequences include patient morbidity, poor outcomes, and even death.  The problem is that there is so much EMR/EHR data.  Professionals need to know where to find the needed (or missing) information in the EMR and EHR, both within clinical and legal practice.    

Elements of the EMR and EHR to Consider for Discovery (including, but not limited to:)

• Name of EMR/EHR, EMR/EHR version, vendor representative contact, technician support service member contact
• Each component part, section, sub-section of the systems
• When the EMR/EHR system was originally implemented and when any upgrades were installed
• The programs capabilities and limitations, how and where entries are made, who can make entries, how dates and times are entered, who has access to the EMR/EHR
• Does the EMR have pre-set standard responses (E.g., automatic times for medication administration), are templates used for the pre-set standard responses, number of templates created or used to create the EMR
• Are electronic signatures (e-signatures) used,  if so which health care providers (HCPs) are assigned and use e-signatures, do medical and nursing staff share signature blocks, does the facility and/or provider have a policy specific to the use of signature blocks and passwords
• Is there a requirement to verify entries of unlicensed staff, if so, which entries must be verified
• Is there a policy specific to making corrections to the EMR/EHR
• Is the EMR, or section of the EMR printed, is so when (E.g., daily, or at the end of admission)
• How is the EMR/EHR secured, who is responsible for security
• Downtime policies (precautions to secure the EMR/EHR, as well as policies specific to documentation)

P.S. Comment and share how the presence, or absence of specific documentation either bolstered or weakened a recent case.

P.P.S. Comment and share if strong knowledge of the EMR/EHR system was able to better support your case.

Reference:

McBride S., & Tietze M. (2019). Nursing informatics for the advanced practice nurse. Patient safety, quality, outcomes, and interprofessionalism. (2^nd ed.) Springer Publishing Company.